Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000624482
Ethics application status
Approved
Date submitted
7/04/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the effect of a Self-Help Model on the Quality of Life and Mental Well-being of School Going Young Caregivers in Pakistan (CARER-HELP)
Scientific title
Feasibility and Efficacy of WHO Self-Help-Plus Model on the Health of Young Carers: A School-Based Intervention
Secondary ID [1] 314142 0
Nill
Universal Trial Number (UTN)
Trial acronym
CARER-HELP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of Life 336966 0
Psychological distress 336965 0
Resilience 336968 0
Condition category
Condition code
Mental Health 333434 333434 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 333433 333433 0 0
Anxiety
Public Health 333435 333435 0 0
Health promotion/education
Mental Health 333432 333432 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: SH+ Feasibility & Efficacy Trial for Distressed Young Carers in Pakistan.
This study involves the implementation of the WHO Self-Help Plus (SH+) intervention, tailored to address the needs of young carers (YCs) in Haripur, Pakistan. SH+ is a low-intensity, structured, and scalable psychological program developed by the World Health Organization (WHO) to support individuals experiencing significant psychological distress. Grounded in Acceptance and Commitment Therapy (ACT), the intervention promotes mindfulness, stress management, and values-based action to enhance psychological well-being and build resilience, ultimately aiming to prevent mental health disorders. The intervention consists of five weekly group sessions, each lasting 90–120 minutes, delivered over a period of 1.5 months (35 days). Sessions are held in safe and comfortable settings such as school computer labs, with group sizes ranging from 19 to 20 participants to foster peer interaction and support. A manualized protocol guides the sessions to ensure consistency across facilitators. The content is based on WHO’s standardized SH+ program, a publicly available resource that mainly includes pre-recorded audio materials with evidence-based content and mindfulness exercises, as well as an additional structured self-help booklet with similar content for supplementary home practice. The core focus areas include stress awareness, self-efficacy, and values-based goal setting. Each of the five sessions is complemented by one corresponding practice activity, introduced sequentially during the sessions and assigned for additional practice at home. These include: (1) Grounding—focusing attention on sensory input and reconnecting with the present moment; (2) Unhooking—identifying and labeling difficult thoughts and emotions, followed by mindful refocusing; (3) Acting on Values—choosing small actions aligned with personal values and planning their implementation; (4) Being Kind—cultivating self-compassion through kind inner dialogue and self-soothing gestures; and (5) Making Room—mindfully noticing, naming, and allowing difficult emotions to pass without resistance. These exercises, outlined in the SH+ printed booklet and supported by audio tools, are reinforced through repetition—once during in-person sessions which is mandatory and once through self-directed practice at home. To encourage compliance, participants who miss their home practice are given the opportunity to complete it individually in class before the next session. Facilitators promote engagement by reviewing each participant’s intended home practice at the end of every session and discussing their experiences through self-report checklists and group reflections at the start of the next. A post-assessment form from the SH+ manual is also used to document participation and identify any barriers. Although home practice is voluntary and not directly monitored or assessed as a formal study outcome—since completion remains at the participants’ discretion—it is considered a critical component of the intervention and is actively supported throughout the sessions to ensure effective skill acquisition. Graduate psychologists serve as facilitators and receive in-person training through a two-week Training of Trainers (ToT) program based on WHO’s SH+ training manual and presentation materials available on the WHO website. The training includes didactic lectures on ACT principles, SH+ content, and mental health topics; practical role-plays and mock sessions with trainer feedback; sessions on cultural adaptation, ethical delivery, and safeguarding; and supervised, peer-reviewed practice using SH+ materials. The WHO-recommended training format includes approximately 40 hours of interactive, in-person sessions. This is supplemented by ongoing supervision from experienced mental health professionals, including a licensed clinical psychologist and the project’s co-supervisor. Weekly supervision meetings during the intervention delivery phase ensure fidelity to the manual, provide implementation support, and help facilitators address emerging challenges. Fidelity monitoring tools include facilitator logs, adherence checklists, and participant engagement records. Participant acceptability, feasibility, and therapeutic alliance are also assessed through validated tools such as the FAAIM, WAI-SR, CSQ-8, and CEQ. These strategies collectively ensure that the intervention is delivered consistently, culturally sensitively, and effectively.
Intervention code [1] 330730 0
Behaviour
Intervention code [2] 330732 0
Prevention
Comparator / control treatment
In this randomized controlled trial, participants in the control group received no therapeutic intervention aside from a single introductory session that provides a general overview of the Self-Help Plus (SH+) intervention. This session, lasting approximately 50-60 minutes, lacks the structured components and therapeutic elements of the actual SH+ program and is intended solely to ensure ethical responsibility by offering minimal engagement to all participants. The session is conducted by graduate-level psychologists who are trained in the SH+ framework, but will not involve any active therapeutic techniques or distribution of SH+ materials. No additional sessions or follow-up activities are provided to the control group. This minimal-intervention control condition is designed to preserve the scientific integrity of the study while offering basic engagement. It also allows for a clear comparison with the intervention group. To evaluate outcomes, the same validated assessment tools will be administered to both groups before and after the intervention period, ensuring consistency in measurement and facilitating accurate comparisons.
Control group
Active

Outcomes
Primary outcome [1] 341004 0
Change in mental well-being among participants
Timepoint [1] 341004 0
Baseline (Week 0, pre-intervention), Post-intervention (Week 6, immediately after final session, primary timepoint), Follow-up (3 months after the intervention).
Primary outcome [2] 341003 0
Change in psychological distress among participants
Timepoint [2] 341003 0
Baseline (Week 0, pre-intervention before the intervention commencement), Post-intervention (Week 6, immediately after final session, primary timepoint), Follow-up (3 months after the intervention).
Secondary outcome [1] 445764 0
Therapeutic alliance between facilitators and participants
Timepoint [1] 445764 0
Week 3 (mid-intervention), Week 6, (post-intervention, immediately after final session)
Secondary outcome [2] 445766 0
Perceived expectancy credibility of the intervention
Timepoint [2] 445766 0
Week 1 (pre-first intervention session), Week 6, (post-intervention, immediately after final session)
Secondary outcome [3] 445767 0
Intervention fidelity and adherence These will be assessed together as a composite secondary outcome for intervention fidelity and adherence.
Timepoint [3] 445767 0
Weekly (Week 1 to Week 6) post-intervention commencement
Secondary outcome [4] 445761 0
Change in health-related quality of life
Timepoint [4] 445761 0
Baseline (Week 0, pre-intervention), Post-intervention (Week 6, immediately after final session), Follow-up (3 months after the intervention).
Secondary outcome [5] 445768 0
Participant attendance and engagement These will be assessed together as a composite secondary outcome for participant attendance and engagement.
Timepoint [5] 445768 0
Weekly (Week 1 to Week 6) post-intervention commencement
Secondary outcome [6] 445765 0
Participant satisfaction with the intervention
Timepoint [6] 445765 0
Week 6, (post-intervention, immediately after final session)
Secondary outcome [7] 445762 0
Change in self-efficacy
Timepoint [7] 445762 0
Baseline (Week 0, pre-intervention), Post-intervention (Week 6, immediately after final session), Follow-up (3 months after the intervention).
Secondary outcome [8] 445763 0
Stakeholder perspectives on implementation
Timepoint [8] 445763 0
Post-intervention (Week 6, immediately after final session) administered only to stakeholders (educators and staff etc)

Eligibility
Key inclusion criteria
1. Participants:
i. Students currently enrolled in grades 9 to 12 at public secondary schools within the Haripur District, Hazara Division, KPK, Pakistan.
ii. Identified as primary caregivers for family members with chronic illness, disability, or age-related health issues, as assessed by the Multidimensional Assessment of Caring Activities – Young Carers (MACA-YC18) tool with a score of 10 and above.
iii. Psychological Distress: Scoring 17 or higher on the Kessler Psychological Distress Scale (K10), indicating moderate to severe psychological distress.
iv. Negative Outcomes of Caring: Scoring 9 or higher on the Positive and Negative Outcomes of Caring Scale (PANOC-YC20).
v. Ability to communicate in Urdu or English, the languages in which the WHO SH+ intervention has been adapted.
2. Schools:
i. Public higher secondary schools located in District Haripur that are willing to participate in the study (Schools located within the 3 sub-districts of the Haripur Hazara).
ii. Schools with adequate facilities to support the intervention delivery (e.g., computer rooms for audio-visual facilities).
3. Consent:
i. Written informed consent obtained from students aged 18 or above.
ii. For participants under 18 years, assent will be obtained alongside written parental/guardian consent.
iii. Permission obtained from school authorities to conduct the trial.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Students with severe mental distress, indicated by a K10 score of 30 and above, or those exhibiting suicidal ideation as assessed during screening.
2. Students diagnosed with severe psychiatric conditions (e.g., psychosis or bipolar disorder) or receiving current psychological/psychiatric treatment, as reported by school counselors or parents.
3. Students who have participated in similar mental health interventions within the past year.
4. Students who have recently changed schools, preventing continuity in participation.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomization process was carried out by the Principal Supervisor to maintain ‘allocation concealment’ (using centralized computer-generated randomization) in accordance with the CONSORT guidelines for conducting RCTs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomization sequence was used. Stratified block randomization was employed based on school gender (boys/girls) and number of psychologically distressed YCs identified per school.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was determined using G*Power software with an estimated medium effect size (Cohen’s d = 0.5), power = 0.80, and a = 0.05. The sample was adjusted for design effect due to cluster randomization.
Statistical analysis will be conducted using SPSS Version 24.0. Statistical analysis will involve mixed-effects models (multilevel modeling) to account for clustering at the school level. Baseline characteristics will be compared using chi-square and t-tests, and outcomes analyzed using ANCOVA or generalized linear mixed models (GLMMs) as appropriate. Missing data will be handled using multiple imputation techniques.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
19/09/2024
Date of last participant enrolment
Anticipated
Actual
26/01/2025
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
160
Accrual to date
Final
150
Recruitment outside Australia
Country [1] 26952 0
Pakistan
State/province [1] 26952 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 318652 0
Self funded/Unfunded
Name [1] 318652 0
Country [1] 318652 0
Primary sponsor type
Individual
Name
Shahbaz Ahmad Zakki - The University of Haripur
Address
Country
Pakistan
Secondary sponsor category [1] 321073 0
Individual
Name [1] 321073 0
Muhammad Ateeb - The University of Haripur
Address [1] 321073 0
Country [1] 321073 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317263 0
Research Ethics/Bioethics committee University of Haripur
Ethics committee address [1] 317263 0
Ethics committee country [1] 317263 0
Pakistan
Date submitted for ethics approval [1] 317263 0
13/11/2023
Approval date [1] 317263 0
12/12/2023
Ethics approval number [1] 317263 0
UOH/DASR/2023/1818

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140502 0
A/Prof Shahbaz Ahmad Zakki
Address 140502 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
Country 140502 0
Pakistan
Phone 140502 0
+92995615330
Fax 140502 0
Email 140502 0
[email protected]
Contact person for public queries
Name 140503 0
Muhammad Ateeb
Address 140503 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
Country 140503 0
Pakistan
Phone 140503 0
+923357333383
Fax 140503 0
Email 140503 0
[email protected]
Contact person for scientific queries
Name 140504 0
Shahbaz Ahmad Zakki
Address 140504 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
Country 140504 0
Pakistan
Phone 140504 0
+923336362383
Fax 140504 0
Email 140504 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
• Development of context-specific intervention adaptations for low- and middle-income countries

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Requests will be reviewed by the Principal Investigator and ethics board.
Data will be shared only in compliance with the participant consent agreement and ethical guidelines.
Sensitive adolescent data may have additional safeguards.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] Ethical Approval UOH.pdf
Ethical approval  [email protected] Schools Ethical Permission.pdf
Informed consent form  [email protected] Informed Consent Child+Parents.pdf
Study protocol  [email protected] Study-Protocol PhD Synopsis 2025.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.